FDA.reportPublic FDA data

Badger Baby Sunscreen Cream Broad Spectrum SPF 40

Manufacturer
W.S. Badger Company, Inc.
Effective date
2024-12-31
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:50:12

Key Label Information#

Active Ingredients And Purpose

Active Ingredient

Non-Nano Uncoated Zinc Oxide 22.5%

Purpose

Sunscreen

Uses

Uses

Helps prevent sunburn If used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

Warnings

For external use only

Directions And Dosage

Directions

For full protection, apply liberally (2mg/cm 2 of skin) to all exposed skin 15 minutes before sun exposure, then rub in to reduce whitening effect. Reapply: After 40 minutes of swimming or sweating Immediately after towel drying At least every 2 hours Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging To decrease this risk, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10am-2pm Wear long-sleeved shirts, pants, hats, and sunglasses For children under 6 months of age: ask a doctor.

Other Label Information

Ingredients

*Helianthus Annuus ( Sunflower ) Seed Oil, *Cera Alba ( Beeswax ), *Simmondsia Chinensis ( Jojoba ) Seed Oil, Tocopherol ( Sunflower Vitamin E ), *Calendula Officinalis ( Calendula ) Flower Extract, *Anthemis Nobilis ( Roman Chammomile ) Flower Oil, *Hippophae Rhamnoides ( Seabuckthorn ) Fruit Extract. *= Organic

Other Information

Protect the product in this container from excessive heat and direct sunlight.

PRINCIPAL DISPLAY PANEL - 87 mL Tube Label

BADGER ® Baby Mineral Sunscreen Cream Broad Spectrum SPF 40 WATER RESISTANT 40 min Powered by Solar Recycled Package Gluten Free Cruelty Free NSF REEF FRIENDLY Certified B Corporation Nourishing & Gentle Pediatrician Tested 98% Organic Ingredients Clear Zinc Oxide 87ml/2.9 fl.oz

Label Images#

TU47128-LA SPF40 Baby Clear v2
TU47128-LA SPF40 Baby Clear v2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62206-4011-12024-12-31C16284748780-11030e364-fc79-111a-e063-dadaa90a10e2Badger ® Baby Mineral Sunscreen Cream Broad Spectrum SPF 40
62206-4011-12024-01-30C16284748780-11030e364-fc79-111a-e063-dadaa90a10e2Badger ® Baby Mineral Sunscreen Cream Broad Spectrum SPF 40

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62206-4011-1Badger Baby Sunscreen Cream Broad Spectrum SPF 4087 mL in 1 TUBECREAM872

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62206-4011BADGER BABY SUNSCREEN CREAM BROAD SPECTRUM SPF 40 (ZINC OXIDE) CREAM [W.S. BADGER COMPANY, INC.]2Current NDC, Legacy NDC, 1 package rows20250101_d61acaa0-73ef-eccf-e053-2995a90ad940.zip

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62206-401162206-4011-1

Ingredients#

Name, UNII, Kind table
NameUNIIKind
SUNFLOWER OIL3W1JG795YIIACT
YELLOW WAX2ZA36H0S2VIACT
TOCOPHEROLR0ZB2556P8IACT
HIPPOPHAE RHAMNOIDES FRUITAVL0R9111TIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
CHAMOMILE FLOWER OIL60F80Z61A9IACT
JOJOBA OIL724GKU717MIACT
ZINC OXIDESOI2LOH54ZACTIB

Complete SPL Sections#

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Non-Nano Uncoated Zinc Oxide 22.5%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

Helps prevent sunburn If used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

WARNINGS SECTION

For external use only

Directions

DOSAGE & ADMINISTRATION SECTION

For full protection, apply liberally (2mg/cm 2 of skin) to all exposed skin 15 minutes before sun exposure, then rub in to reduce whitening effect. Reapply: After 40 minutes of swimming or sweating Immediately after towel drying At least every 2 hours Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging To decrease this risk, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10am-2pm Wear long-sleeved shirts, pants, hats, and sunglasses For children under 6 months of age: ask a doctor.

Ingredients

INACTIVE INGREDIENT SECTION

*Helianthus Annuus ( Sunflower ) Seed Oil, *Cera Alba ( Beeswax ), *Simmondsia Chinensis ( Jojoba ) Seed Oil, Tocopherol ( Sunflower Vitamin E ), *Calendula Officinalis ( Calendula ) Flower Extract, *Anthemis Nobilis ( Roman Chammomile ) Flower Oil, *Hippophae Rhamnoides ( Seabuckthorn ) Fruit Extract. *= Organic

Other Information

STORAGE AND HANDLING SECTION

Protect the product in this container from excessive heat and direct sunlight.

PRINCIPAL DISPLAY PANEL - 87 mL Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BADGER ® Baby Mineral Sunscreen Cream Broad Spectrum SPF 40 WATER RESISTANT 40 min Powered by Solar Recycled Package Gluten Free Cruelty Free NSF REEF FRIENDLY Certified B Corporation Nourishing & Gentle Pediatrician Tested 98% Organic Ingredients Clear Zinc Oxide 87ml/2.9 fl.oz

Source Document#

Source XML